A 1-year Randomised, Double-blind Placebo-controlled Study to Evaluate the Effects of Memantine on Rate of Brain Atrophy in Patients With Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 277
- 主要终点
- Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI)
研究概览
简要总结
Pre-clinical studies have demonstrated that memantine can decrease the neuronal toxicity associated with excessive glutamate release and calcium overload in neurons. Previous studies have shown that memantine helps to treat the symptoms of Alzheimer's Disease (AD). In AD, the rate of brain tissue loss, or atrophy, is faster than in normal aging and this seems to go hand in hand with some of the symptoms of the disease. This suggests that memantine treatment in AD could provide both symptomatic improvement and neuro-protective effects. The purpose of this study was to show whether memantine, in addition to providing symptomatic benefits, can slow the rate of brain atrophy as assessed using magnetic resonance imaging (MRI) technology.
详细描述
The primary objective of this study was to evaluate the effects of memantine on the rate of brain atrophy compared to placebo in patients with AD (moderate severity) over a 1-year period. This was a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study (20 mg memantine). The study also included secondary imaging, cognitive and behavioural measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients at least 50 years of age with a current diagnosis of probable AD of moderate severity (MMSE score between 12 and 20, inclusive) consistent with NINCDS-ADRDA criteria and MRI scans
- •Patients must have had a knowledgeable and reliable caregiver to accompany them to all clinic visits during the study
- •Patients were either on or off existing acetylcholinesterase inhibitor (AChEI) treatment provided that the treatment had been initiated >6 months prior to screening, had stabilised with respect to dose for >3 months, and remained fixed during the entire study. AChEI treatment could not be initiated or modified during the study
排除标准
- •The patient had evidence of clinically significant active disease (including recent myocardial infarction and uncompensated congestive heart failure [NYHA II-IV])
- •The patient had evidence of any clinically significant neurodegenerative disease or neurological disorder other than AD
- •The patient was contraindicated for MRI
- •Other protocol-defined inclusion and exclusion criteria applied.
研究组 & 干预措施
Memantine
干预措施: Memantine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Total Brain Atrophy Rate Estimated Using Brain Boundary Shift Integral (BBSI)
时间窗: Baseline to 1 year
Measures direct changes in total brain volume per visit interval (screening to Week 4, 42, or 52 or from Week 4 to Week 42 or 52)
次要结局
- Changes in Total Hippocampal Volume (HCV)(Baseline to 1 year)
- Cognitive and Behavioural Outcomes: Controlled Oral Word Association Test (COWAT) Total Score(Baseline to 1 year)
- Cognitive and Behavioural Outcomes: Mini Mental State Examination (MMSE) Total Score(Baseline to 1 year)